POEClass III

Extended Depth Of Focus Intraocular Lens

21 CFR 886.3600 / Ophthalmic

POE is the FDA product code for Extended Depth Of Focus Intraocular Lens, a class III device type, regulated under 21 CFR 886.3600. FDA's definition for this code reads: "Intended to be implanted to replace the natural lens of an eye". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: POE
Device name: Extended Depth Of Focus Intraocular Lens
FDA definition: Intended to be implanted to replace the natural lens of an eye.
Regulation: 21 CFR 886.3600
Device class: Class III
Review panel: Ophthalmic
Submission type: PMA
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order

Recent clearances

Product code POE

FDA records hold no clearances under product code POE.

Recent recalls

Product code POE

Z-2288-2023Class IITheir is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.Johnson & Johnson Surgical Vision, Inc. / initiated 2023-07-06 / 42

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)